MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000 UNIVERSAL ROLLER

Model Number 16402

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified that one of the rollers on the pump was loose and not holding occlusion.She was unable to tighten the inner screw on the roller.The roller cap was spinning freely with the rest of the roller and could not be unscrewed from the roller base.As a result, the roller pump was replaced.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the cardioplegia pump was not holding occlusion.The occlusion was set correctly but it was lost after a few pump rotations.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician observed that when the roller pump was running overnight it had unscrewed itself, creating a pump jam error.It was found that the gut assembly was the cause of the problem.

Event Description

Per clinical review: on 25-feb-2020, the team placed the 4:1 cardioplegia (cpg) roller pump was placed in the roller head, primed, occlusion set as normal, per protocol for the procedure.Shortly after commencing cardiopulmonary bypass, it was noticed that the roller pump would not hold occlusion, they tightened the occluded knob, and it would still not hold the occlusion appropriately to deliver the correct cpg amount.The team then decided to move the disposable set to an open roller pump, and had no concern the remainder of the procedure.There was no harm or blood loss associated with the event.The incident did not delay the continuation of the surgical procedure.

Manufacturer Narrative

The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000 UNIVERSAL ROLLER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9857291
• MDR Text Key: 199227775
• Report Number: 1828100-2020-00132
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention